Study identification

PURI

https://redirect.ema.europa.eu/resource/36212

EU PAS number

EUPAS28457

Study ID

36212

Official title and acronym

An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers

DARWIN EU® study

No

Study countries

Germany
Ireland
Spain
United Kingdom

Study description

Psoriasis is a chronic inflammatory skin disorder that results from complex interactions between genes, the immune system, and environmental factors, although the exact cause remains unclear. Skilarence (dimethyl fumarate, DMF) received European marketing authorisation for the treatment of moderate to severe chronic plaque psoriasis in adult patients on 23 June 2017.This study aims to evaluate the long-term safety of Skilarence used for the treatment of patients with moderate to severe psoriasis. The study will evaluate whether the use of Skilarence is associated with an increased risk of serious infections (including serious opportunistic infections such as progressive multifocal leukoencephalopathy), malignancies, or renal impairment as compared with conventional (non-biologic) systemic therapies. In addition, the study aims to describe the use of Skilarence in patient subgroups for which there is missing information. The study is a long-term, non-interventional, observational post-authorisation safety study that will use a prospective cohort design, and data from established registers of patients with psoriasis treated with systemic therapies in Germany, Spain, and the UK and Ireland.

Study status

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Fundación de la Academia Española de Dermatología y Venereología Madrid, Spain, University Medical Center Hambug-Eppendorf (UKE) Hamburg, Germany, British Association of Dermatologists Biologics Register Limited (BADBIR) Manchester, United Kingdom

Contact details

Elena Rivero

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Almirall S.A.
Study protocol
Initial protocol

0304446_Skilarence PASS Protocol_Final_14Jun2018_signatures redacted

English (864.18 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)